For In Vitro Diagnostic Use.
KingFisher™ Apex Dx Purification Instrument
INSTRUCTIONS FOR USE | IVD
Catalog NumberB5400900P
Document Part Number 100123011
Publication Number MAN0026509
Revision B.0
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Revision history:Pub.No. MAN0026509
Revision Date Description
B.0 5 July 2023
•The document part number was added to the cover page.
•Information directing the user to contact Technical Support for Thermo Fisher-developed IVD
reagents and protocols was added to the Import/Export section.
•Information directing the user to contact Technical Support to secure a protocol compatible with
IVD mode was added to the Import/Export section.
A.0 27 April 2023 New document for KingFisher™ Apex Dx Purification Instrument.
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE
LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR
ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these
products, you accept the terms and conditions of all applicable Limited Use Label Licenses.
NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any
process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled by
Thermo Fisher Scientific, either expressly, or by estoppel.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2023 Thermo Fisher Scientific Inc. All rights reserved.
Contents
■CHAPTER1Productinformation .................................................. 6
Productdescription ............................................................. 6
Intendeduse ................................................................... 6
Orderingconfigurations .......................................................... 6
Product overview ............................................................... 7
Instrument overview ......................................................... 7
User interface overview ...................................................... 9
General login functionalitydescription ............................................ 11
Upon receiving thedevice ....................................................... 11
Precautions foruse ........................................................ 12
Magnetic heads ........................................................... 12
Guidelines for unpacking theinstrument ...................................... 13
First time instrumentsetup .................................................. 13
Instrument components and plasticcompatibility .................................. 16
Heating block and compatible plate .......................................... 16
Magnetichead ............................................................ 18
Tip comb and platecompatibility ............................................ 20
■CHAPTER2Methods ............................................................. 21
Change password .............................................................. 21
Create, edit, or deleteusers ..................................................... 21
Access IVD protocol and load to instrument memory ............................... 22
Run purificationkit ............................................................. 22
Abortrun ..................................................................... 24
Turn o theinstrument .......................................................... 24
Change heat block/magnetichead ............................................... 24
Unload heatingblock ....................................................... 24
Unload magnetichead ..................................................... 25
KingFisher™ Apex Dx Purification Instrument Instructions for Use 3
■CHAPTER3Softwareapplications .............................................. 27
About the user interface ........................................................ 27
Users and roles ............................................................ 27
Diomni™ and SAE integration ................................................ 27
IVD mode(local) ............................................................... 29
Switch instrumentmode .................................................... 29
Overview of user interface controls ............................................... 30
Home screen .............................................................. 30
Menu screen .............................................................. 31
Settings screen ............................................................ 31
Protocolsettings .......................................................... 33
Soundsettings ............................................................ 34
About .................................................................... 34
Usersettings .............................................................. 35
Instrument screen ......................................................... 36
Protocol overview .............................................................. 37
Import/Export overview ......................................................... 37
Import protocol from a USB memorydevice ................................... 37
Export protocol to a USB memorydevice ..................................... 37
Run history overview ........................................................... 38
Export run report .......................................................... 38
Delete run report .......................................................... 38
Searchruns ............................................................... 38
Telemetrydata ................................................................. 39
■APPENDIXATroubleshooting .................................................... 41
Troubleshootingguide .......................................................... 41
■APPENDIXBMaintenance ....................................................... 44
Regular and preventive maintenance ............................................. 44
Store transportlock ............................................................ 44
Magnetic head maintenance ..................................................... 45
Decontamination procedure ..................................................... 45
Decontaminateinstrument .................................................. 45
UV decontamination procedure .................................................. 46
UV treat processchamber .................................................. 46
Prepare instrument for transport ................................................. 46
Refit the transportlock ..................................................... 46
Contents
4KingFisher™ Apex Dx Purification Instrument Instructions for Use
■APPENDIXCSpecifications ...................................................... 48
Physicaldimensions ............................................................ 48
Instrumentspecifications ....................................................... 48
Performancespecifications ...................................................... 49
■APPENDIXDOrderinginformation .............................................. 51
Orderingconfigurations ......................................................... 51
■APPENDIXESafety ............................................................... 53
Safetycompliance ............................................................. 53
■APPENDIXFSymbols on thisinstrument ....................................... 54
Medical devicesymbols ........................................................ 54
Standard safetysymbols ........................................................ 55
■APPENDIXGElectromagnetic compatibility (EMC) standards ................ 56
EMCcompliance ............................................................... 56
Physical injury ................................................................. 57
Electricalsafety ................................................................ 57
Chemicalsafety ................................................................ 59
Biological hazardsafety ......................................................... 60
■APPENDIXHSeriousincidents .................................................. 61
■APPENDIXIDocumentation and support ....................................... 62
Customer and technical support ................................................. 62
Limited product warranty ........................................................ 62
Contents
KingFisher™ Apex Dx Purification Instrument Instructions for Use 5
Product information
Product description
The Thermo Scientific™ KingFisher™ Apex Dx Purification Instrument is intended for automated transfer
and processing of magnetic particles in a microplate format. The instrument utilizes magnetic heads
covered with a disposable, specially designed tip comb, and plates. The instrument functions without
any dispensing or aspiration parts or devices. Before the run, samples and reagents (including magnetic
particles) are dispensed into the place according to default, uneditable or uncustomizable in vitro
diagnostic (IVD) protocols.
For the product information sheet on the magnetic heads or the quick reference card on instrument
installation see the following documents:
•KingFisher™ Apex Dx Heads Product Information Sheet (Pub. No. MAN0029197)
•KingFisher™ Apex Dx Purification Instrument Quick Reference (Pub. Part No. 100109527)
Intended use
The KingFisher™ Apex Dx Purification Instrument is intended to automate the process of isolation and
purification of nucleic acids, proteins and cells for in vitro diagnostics (IVD) procedures in combination
with a dedicated purification kit. The instrument is intended for use by professional users, such as
technicians and physicians trained in molecular biological techniques.
Ordering configurations
The KingFisher™ Apex Dx Purification Instrument is available to order in combination with one of four
dierent magnetics heads as outlined in the following table. The following catalogue numbers are used
for customer ordering purposes only.
Details Cat. no. Cat. no.
B5400910
Cat. no.
B5400920
Cat. no.
B5400930
Cat. no.
B5400940
Instrument
KingFisher™ Apex Dx Purification Instrument B5400900P 1 1 1 1
Components of instrument
UV lamp N21447 2 2 2 2
3-mm flat-tip driver MLS 1 1 1 1
1
6KingFisher™ Apex Dx Purification Instrument Instructions for Use
(continued)
Details Cat. no. Cat. no.
B5400910
Cat. no.
B5400920
Cat. no.
B5400930
Cat. no.
B5400940
Heating blocks
PCR Heating Block 24075910 1 — — —
96 Heating Block 24075920 1 1 1 —
96 Deep Well Heating Block 24075930 — 1 1 —
24 Deep Well Heating Block 24075940 — — — 1
Magnetic heads
KingFisher™ Apex Dx 96 PCR Head B24079910 1 — — —
KingFisher™ Apex Dx 96 Combi Head B24079920 — 1 — —
KingFisher™ Apex Dx 96 Deep Well Head B24079930 — — 1 —
KingFisher™ Apex Dx 24 Combi Head B24079940 — — — 1
Product overview
Instrument overview
The KingFisher™ Apex Dx Purification Instrument consists of a touch screen control and a process
chamber with lid to protect specimens and processing plates against environmental contamination.
Figure1KingFisher™ Apex Dx Purification Instrument front view
1Front lid
2Touch screen
3On/o button
4USB port × 3 (Host)
Chapter1Product information
Product overview 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 7
1
346
5
2
Figure2KingFisher™ Apex Dx Purification Instrument rear view
1Power switch
2Power inlet
3Ethernet/LAN port
4USB port (Host) × 2
5RS-232 serial port
6USB port (Device)
Internal layout
The process chamber of the KingFisher™ Apex Dx Purification Instrument consists of a turntable with
eight plate stations. The loading position has an illuminated display, while the processing position is
situated over the heating block and underneath the processing head. There are two heating block
stations under the turntable (not shown on picture) that can be selected for applying to the processing
position.
The processing head consists of two vertically moving platforms—the magnetic head holder, and the
tip comb holder. The magnetic head holder is used to attach up to two magnetic heads composed of
24 or 96 magnetic rods, while the tip comb holder is used to hold plastic tip combs with 24 or 96 tips.
Chapter1Product information
Product overview
1
8KingFisher™ Apex Dx Purification Instrument Instructions for Use
Figure3Process chamber layout
1Turntable with plate stations (1–8)
2Processing position
3Loading position
4Tip comb holder
5Magnetic head holder
6Shield plate
7Barcode reader
8UV light clip × 2
9UV light socket × 2
User interface overview
Symbol Function
Notifications screen (For more details, see “Home screen” on page30)
Swipe down from the top of the touch screen
Displays the following information:
•Notifications
•Internet status
•Storage devices
Chapter1Product information
Product overview 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 9
(continued)
Symbol Function
Menu screen (For more details, see “Menu screen” on page31)
Select Menu
Gives access to the following items:
•Home
•Run history
•Import/Export
•Settings
•Instrument
•User management
Settings screen (For more details, see “Settings screen” on page31)
Select Menu4Settings
Gives access to the following items:
•Localization
•Protocols
•Sound
•Loading position display
•Network share
•About
•Reset factory settings
•Troubleshoot
•View EULA
Instrument screen (For more details, see “Instrument screen” on page36)
Select Menu4Settings
Gives access to the following items:
•Tools
•Magnets
•Heating blocks
Chapter1Product information
Product overview
1
10 KingFisher™ Apex Dx Purification Instrument Instructions for Use
General login functionality description
The KingFisher™ Apex Dx Purification Instrument has a login functionality. The user can log in to
the instrument locally or via Security, Auditing, and E-Signature (SAE) server (if Applied Biosystems™
Diomni™ Software and SAE integration is enabled). See “Enable Diomni™ Software and SAE integration”
on page27.
The instrument has two modes: research use only (RUO) and IVD. The purpose of this instructions for
use is solely for IVD mode. The IVD mode is available when logged in locally or via SAE.
When the instrument is used by logging in locally, only locally available IVD protocols can be used and
are not customizable.
When the instrument is used while logged in via SAE, the usage is limited to work with Run tasks
created through Diomni™ Software. The IVD Run tasks are available in IVD mode. The user can switch
between Local-Login and SAE-Login (if enabled).
Upon receiving the device
• Visually inspect the transport package, the instrument and the accessories for any damage
incurred during transit.
• If the carton has been damaged in transit, it is particularly important that you retain it for inspection
by the carrier in case there has also been damage to the instrument.
• Any damage claims must be filed with the carrier. Neither the manufacturer nor its agents can be
held responsible for any damage incurred in transit. Upon receipt of the carrier's inspection report,
arrangements will be made for repair or replacement.
Chapter1Product information
General login functionality description 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 11
Precautions for use
CAUTION! PHYSICAL INJURY HAZARD. Do not remove the instrument cover. There are no
components inside the instrument that you can safely service yourself. If you suspect a problem,
contact technical support.
CAUTION! PHYSICAL INJURY HAZARD. The instrument weighs 56 kg (123 lbs) and requires at
least two people to lift. Use the properprecautions when lifting the instrument to avoid injury..
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the heating block
temperature can reach 100°C. Allow it to cool to room temperature before handling.
CAUTION! Before using a cleaning or decontamination method other than those recommended by
Thermo Fisher Scientific, confirm with Thermo Fisher Scientific that the proposed method will not
damage the instrument. See “Decontaminate instrument” on page45.
Magnetic heads
WARNING! This product contains very strong permanent magnets. People wearing a pacemaker
or metallic prosthesis should not use this product. A pacemaker or prosthesis may be aected or
damaged if it comes in close contact with a strong magnetic field.
There are four kinds of interchangeable magnetic heads with corresponding disposable plastic tip
combs available for the instrument. The magnetic head holder has two positions that can be used to
hold dierent types of magnetic heads.
IMPORTANT! Keep magnetic heads away from each other and other magnets at all times. Clashing of
the magnets can cause serious damage to the magnets.
•Do not place the magnetic head on top of the instrument or on any metal surfaces.
•Do not use metal tools when handling magnetic heads.
•Do not place the magnetic head in close proximity to magnetic tapes, computer discs or other
magnetic storage systems, such as credit cards, as damage can occur due to the strong magnetic
field of the magnetic heads.
•Do not place the magnetic heads near a PC display, as this may cause damage to the display.
•When not in use, keep the magnetic heads in their respective storage boxes.
•For details on changing a magnetic head, see “Change heat block/magnetic head” on page24.
Chapter1Product information
Upon receiving the device
1
12 KingFisher™ Apex Dx Purification Instrument Instructions for Use
Guidelines for unpacking the instrument
• To prevent condensation, the instrument should be left in its protective, antistatic plastic wrapping
until the ambient temperature has been reached.
• Retain the original packaging and packing material for future transportation. The packaging is
designed to assure safe transport and minimize transit damage. Use of alternative packaging
materials may invalidate the warranty. Also retain all instrument-related documentation provided by
the manufacturer for future use.
First time instrument setup
The initial installation and initial operational check (IQ/OQ) must be performed by FSEs. Content should
be retained for the instances where there is an emergency by the end user.
1. Connect the power supply cable to the power inlet.
The instrument operates at voltages of 100–240 VAC and the frequency range of 50/60 Hz. Ensure
that the local supply voltage in the laboratory conforms to that specified on the type label on the
back of the instrument
2. Remove the transport lock screw from the magnet holder.
3. Remove the transport lock screws from the transport lock plate over the tip comb holder.
3
2
4. Remove the upper transport lock plate, then lift the tip comb holder and remove the lower
transport lock plate.
Do not discard the parts of the transport lock. The lock is required in case of future transportation
of the instrument (see “Store transport lock” on page44).
Chapter1Product information
Upon receiving the device 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 13
Install the UV light bulbs
1. Insert the UV light bulb into the light clip.
2. Slide the light bulb back and into the light socket.
1
2
Power on the instrument
1. Turn on the power switch at the rear of the instrument.
2. Press the on/o button to turn on the instrument.
Log in to KingFisher™ Apex Dx Purification Instrument for first time as administrator
1. At initial login, create username and password for administrator.
Note: Create a username and password that contains at least six characters, and may contain
upper- and lower-case letters, numbers, and special characters. Not all characters are supported.
IMPORTANT! Only the administrator can create and modify the other user roles.
2. Read the license agreement, then select accept.
3. Choose region.
4. Set date, time, and other selectable options
IMPORTANT! The time set here will be applied in the logging and reporting functions.
Chapter1Product information
Upon receiving the device
1
14 KingFisher™ Apex Dx Purification Instrument Instructions for Use
5. On the Mode selection screen, select IVD mode.
Note: After IVD mode is selected, a new window should open.
Install heating block
1. Select Menu4Instrument.
2. In the Heating blocks section, select Insert for the position (1 or 2). The system will present the
heating block station to allow the user to install the heating block.
3. Scan the heating block to be installed by facing the heating block barcode sticker approximately
8–10 cm from the barcode readinger inside the process chamber.
Note: Alternatively, select the heating block to be installed manually from the list shown on the
screen menu.
4. Place the heating block on the heating block station. Fit the pins on the block into the slots of the
station. Press the block down until it clicks properly into position.
Note: Select Information for details on heating block installation.
5. Select .
Install magnetic head
1. Select Menu4Instrument.
2. Select Insert for the position (1 or 2) to install the magnet.
3. Scan the magnetic head to be installed with the barcode reader or perform manual selection with
the menu.
4. Place the magnetic head onto the holder. Fit the pins on the head into the slots in the holder.
Chapter1Product information
Upon receiving the device 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 15
5. Turn the handle to lock the magnet in place.
Note: Select Information for details on magnetic head installation.
5
4
6. Select .
Instrument components and plastic compatibility
Heating block and compatible plate
The instrument uses specially designed barcoded plates for optimal processing. Use of other types of
plates may damage the instrument and compromise the warranty, as well as result in below optimal
performance.
The heating blocks are specifically designed for the plates listed in the following table to ensure even
heating during sample processing.
For details on changing a heating block, see “Change heat block/magnetic head” on page24.
Heating block Plate
KingFisher™ Apex 24 Deep Well Heating Block,
barcoded (Cat. No. 24075940)
KingFisher™ 24 Deep Well Plate, barcoded (30 µL to
5mL [1], Cat. No. 95040470B)
Chapter1Product information
Instrument components and plastic compatibility
1
16 KingFisher™ Apex Dx Purification Instrument Instructions for Use
(continued)
Heating block Plate
KingFisher™ Apex 96 Deep Well Heating Block,
barcoded (Cat. No. 24075930)
KingFisher™ 96 Deep-Well Plate, barcoded (15–
1000µL [1], Cat. No. 95040450B)
KingFisher™ Apex 96 KF Heating Block, barcoded
(Cat. No. 24075920)
KingFisher™ 96-Well Microplate, barcoded (15–
200µL [1], Cat. No. 97002540B)
KingFisher™ Apex PCR Heating Block, barcoded
(Cat. No. 24075910)
PCR plate (10–80µL [1]), skirted (Cat. No. AB2396 [2])
Chapter1Product information
Instrument components and plastic compatibility 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 17
(continued)
Heating block Plate
Adapter
KingFisher™ Apex 96 PCR Semiskirted Plate Adapter (Cat. No. N21446) or semi-skirted (Cat. No.
AB2496 ) [1]
[1] The fill volume depends on the type of tip comb being used.
[2] Recommended PCR plate
Magnetic head
Magnetic head Tip comb
KingFisher™ Apex Dx 96 PCR Head, barcoded (Cat.
No. B24079910)
KingFisher™ 96 PCR Tip Comb, barcoded (Cat. No.
97002560)
KingFisher™ Apex Dx 96 Deep Well Head, barcoded
(Cat. No. B24079930)
KingFisher™ 96 Tip Comb for Deep Well Magnets,
barcoded (Cat. No. 97002534B)
Chapter1Product information
Instrument components and plastic compatibility
1
18 KingFisher™ Apex Dx Purification Instrument Instructions for Use
(continued)
Magnetic head Tip comb
KingFisher™ Apex Dx 96 Combi Head, barcoded
(Cat. No. B24079920)
KingFisher™ 96 Combi Tip Comb, barcoded (Cat.
No. 97002570)
KingFisher™ Apex Dx 24 Combi Head, barcoded
(Cat. No. B24079940)
KingFisher™ 24 Deep Well Tip Comb, barcoded (Cat.
No. 95040470B)
(also KingFisher™ 24 Combi Tip Comb, barcoded )
Chapter1Product information
Instrument components and plastic compatibility 1
KingFisher™ Apex Dx Purification Instrument Instructions for Use 19
Tip comb and plate compatibility
Tip comb Compatible plates
KingFisher™ 96 Tip Comb for Deep Well Magnets
(Cat. No. 97002534B)
KingFisher™ 96 Deep Well plate (Cat. No.
95040450B)
KingFisher™ 96-Well Microplate (Cat. No.
97002540B)
KingFisher™ 96 Combi Tip Comb (Cat. No.
97002570)
KingFisher™ 96 Deep Well plate (Cat. No.
95040450B)
KingFisher™ 96-Well Microplate (Cat. No.
97002540B)
KingFisher™ 24 Deep Well Tip Comb (Cat. No.
97002610B)
KingFisher™ 24 Deep Well plate (Cat. No.
95040470B)
KingFisher™ 24 Combi Tip Comb (Cat. No.
97002580)
KingFisher™ 24 Deep Well plate (Cat. No.
95040470B)
KingFisher™ 96 PCR Tip Comb (Cat. No. 97002560) PCR plate, skirted (Cat. No. AB2396)
PCR plate, semi-skirted (Cat. No. AB2496)
KingFisher™ 96-well Microplate (Cat. No. 97002540)
Chapter1Product information
Instrument components and plastic compatibility
1
20 KingFisher™ Apex Dx Purification Instrument Instructions for Use
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